Avenue T AT9046R

GUDID 03662663024044

TRIAL H8MM 0°

LDR Spine Usa, Inc.

Spinal implant trial

• Primary Device ID: 03662663024044
• NIH Device Record Key: 3187422e-f230-462a-8afd-a6bb2e91be38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenue T
• Version Model Number: AT9046R
• Catalog Number: AT9046R
• Company DUNS: 615789729
• Company Name: LDR Spine Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com

Device Dimensions

• Angle: 0 degree
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Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663024044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161173

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

[03662663024044]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-03-10
• Device Publish Date: 2017-03-21

On-Brand Devices [Avenue T]

• 03662663002882: CAGE HOLDER
• 03662663026024: AT990D
• 03662663026017: AT990C
• 03662663023696: AT990B
• 03662663023689: AT990A
• 03662663024273: TRIAL H19MM 9°
• 03662663024266: TRIAL H18MM 9°
• 03662663024259: TRIAL H17MM 9°
• 03662663024242: TRIAL H16MM 9°
• 03662663024235: TRIAL H15MM 9°
• 03662663024228: TRIAL H14MM 9°
• 03662663024211: TRIAL H13MM 9°
• 03662663024204: TRIAL H12MM 9°
• 03662663024198: TRIAL H11MM 9°
• 03662663024181: TRIAL H17MM 5°
• 03662663024174: TRIAL H16MM 5°
• 03662663024167: TRIAL H15MM 5°
• 03662663024150: TRIAL H14MM 5°
• 03662663024143: TRIAL H13MM 5°
• 03662663024136: TRIAL H12MM 5°
• 03662663024129: TRIAL H11MM 5°
• 03662663024112: TRIAL H10MM 5°
• 03662663024105: TRIAL H14MM 0°
• 03662663024099: TRIAL H13MM 0°
• 03662663024082: TRIAL H12MM 0°
• 03662663024075: TRIAL H11MM 0°
• 03662663024068: TRIAL H10MM 0°
• 03662663024051: TRIAL H9MM 0°
• 03662663024044: TRIAL H8MM 0°
• 03662663024037: TRIAL H7,5MM 0°
• 03662663023672: AVENUE T ANCHORING PLATE "L"
• 03662663023665: AVENUE T ANCHORING PLATE "M"
• 03662663023658: AVENUE T ANCHORING PLATE "S"
• 03662663003070: AT9044R
• 03662663003063: AT9043R
• 03662663003056: AT9041R
• 03662663003049: AT9040R
• 03662663003032: AT9039R
• 03662663003025: AT9038R
• 03662663003018: AT9037R
• 03662663002936: AT9042R
• 03662663002912: DOUBLE IMPACTOR
• 03662663002899: IMPACTOR
• 03662663002875: AT9031R
• 03662663002868: AT9030R
• 03662663002851: AT9029R
• 03662663002844: AT9028R
• 03662663002837: AT9027R
• 03662663002820: AT9026R
• 03662663002813: AT9025R